MSAT Scientist III

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.Lonza Houston is looking for a Manufacturing Science and Technology (MSAT) Scientist III. As a member of the MSAT Team, you will be responsible for the successful transfer of viral vector bioprocesses into GMP production. As such, you will be in direct contact with our clients and internal cross-functional teams. You will ensure successful process scalability and manufacturability. Scientists in this role are responsible for all the process integration-related aspects of work during campaign preparation, process supervision, reporting during and after production campaigns, leading relevant major deviations, and continuing manufacturing process improvement under the supervision of a Sr. Scientist and/or Manager.Key responsibilities:This individual will utilize process flow diagrams, learned expertise, and transferred data to transfer detailed, step-by-step manufacturing processes under the supervision of a senior MSAT scientist and/or manager of MSAT.This position has responsibilities that can be exemplified by the technology transfer of all aspects of buffer and media production, cell thaw and culturing, harvesting, purification, and/or bulk filling of drug substance.This person will perform portions of process transfer from either PD Lonza or from customers, commensurate with their experience and under GMP conditions.This person will utilize project and time management skills to ensure that all tasks are completed in a timely manner, and that risks to project execution are raised in a timely manner to senior engineer(s), project management, and/or MSAT management as appropriate.The position will support new product introductions (NPI/technology transfers) with minimized assistance from the senior engineer associated with a project, as well as ongoing manufacturing runs by correcting errors noted in previous runs, observing processing on-the-floor (under the supervision of a senior scientist), and overseeing operations within their area of subject matter knowledge to assure planned, predictable operations.The individual gains mastery of various unit operations, the science behind it, and associated process analysis techniques, and applies them, continuing the journey from individual contributor to subject matter expert in either upstream or downstream processing.This individual will pursue successful resolution of complex quality system deviations from expected results, driving for holistic and/or targeted solutions to ensure process and product quality and the smooth, on-time delivery of batches to our clientele.This position is likely to participate in more complex tasks such as the technology transfer and oversight, as well as process improvements, for all process steps, under reduced supervision of the senior MSAT scientist associated with the project.This person may assist in the creation of a full bill of materials for a given program, likely performing materials suitability assessments for appropriate alternatives/second sources for materials needed in conjunction with a junior engineer.GMP manufacturing support (Viral Vector or Cell and Gene Therapy preferred; microbial or mammalian processing support required if VV/CGT background is limited or non-existent), and a basic understanding of current Good Manufacturing Practices, US/EU regulations.Key requirements:Bachelor’s Degree required in a field Related Science. A Master of Science or Ph.D. is preferred in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science fields.Advanced knowledge of cellular biology, cell culture, scale-up, mass transfer, bioreactor operation, and/or depth filtration, tangential flow filtration, chromatography, viral filtration; buffer and media production; aseptic processing.Demonstrates critical thinking skills in problem-solving and decision-making.Ability to explain technical problems in terms sufficient for other technically trained people to understand the problem and proposed solutions, both verbally and in writing.Ability to independently lead small projects and to create, maintain, and utilize the cross-functional support of other departments within the asset for the accomplishment of objectives.Ability to perform basic and advanced root cause analysis techniques for resolving deviations and identifying appropriate CAPA: Five why, Kepner-Tregoe, Fishbone, Pareto, Scatter plotting, DMAIC for RCA.Ability to perform basic risk identification and remediation and lead basic and advanced risk assessments using standardized methodologies which could include FMA, FMEA, HAZOP, and/or HACCP.Attention to detail and high level of accuracy.Some knowledge of statistical data analysis is a plus.Strong communication, technical writing, organizational, and interpersonal skills.People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.

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